K-number	K163633
Device name	cobas HbA1c Test, cobas b 101 system
Applicant	Roche Diagnostics Operations
Product code	LCP
Device class	Class II
Decision date	Jul 28, 2017
Decision	Substantially Equivalent
Regulation	864.7470

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Source

View the full FDA submission: accessdata.fda.gov

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cobas HbA1c Test, cobas b 101 system

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